Marion Gruber, director of the Office of Vaccines Research and Review (OVRR) and 32-year veteran of the agency, has announced to staff that she plans to retire on Oct. 31. OVRR Deputy Director Phil Krause, who has been at the FDA for more than a decade, has also announced that he will be leaving the agency in November.
OVRR is part of the FDA's Center for Biologics Evaluation and Research (CBER).
The pair of announcements came barely a week after the FDA granted full approval to Pfizer's coronavirus (COVID-19) vaccine and as the Biden administration intensified its push for booster doses. (Related: Biden pushes THIRD spike protein "booster" injection on Americans.)
In a memo, CBER Director Peter Marks said he will serve as the acting director of the OVRR while the FDA searches for its next director. The search process will begin immediately, he said. The memo did not give a reason for Gruber's or Krause's departure, but there were reports that they were not happy with the Biden administration's authoritarian COVID-19 vaccine regime.
A former senior FDA leader told independent news organization Endpoints that the two were leaving because they're frustrated that the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) are involved in decisions they think should be up to the FDA.
The former FDA official also said he's heard they're upset with Marks for not insisting that those decisions should be kept inside FDA. He added that the last straw was the White House getting ahead of the FDA on booster doses.
The Biden administration apparently finds ACIP more amenable to its vaccine agenda.
Just recently, the administration jumped ahead of the FDA's reviews of booster doses and announced that they might be available by the week of Sept. 20. The FDA said earlier this year that boosters would not be recommended for the virus. With the COVID-19 vaccines appearing to fail against variants of the virus, it remains unclear what benefits an additional dose would provide.
More and more public health experts are opposing the rollout of boosters. Some are recommending that the virus be allowed to circulate throughout the population, with precautions taken for vulnerable individuals.
"We really cannot do anything else but allow the virus to take its course in order for the population to achieve herd immunity," said Porolfur Gudnason, chief epidemiologist of Iceland's Directorate of Health. "We need to try to vaccinate and better protect those who are vulnerable, but let us tolerate the infection. It is not a priority now to vaccinate everyone with the third dose."
The World Health Organization (WHO) has also rejected calls for COVID-19 vaccine boosters.
"We recently had an expert group meeting with scientists from around the world. It included regulatory experts from different regulatory agencies, and there was consensus that the data around the need for boosters is not conclusive," WHO Chief Scientist Dr. Soumya Swaminathan said at a media briefing on Aug. 25.
"We also don't know about the safety of boosters. When we talk about vaccines, it's not just the efficacy. What happens when you give a third dose of an mRNA vaccine or any other kind of vaccine? These need to be studied as well, so before we launch into full-scale booster programs for the whole population there are a number of questions that need to be answered."
Some are asking whether catching COVID-19 now is better than having more vaccines.
"There are clearly sources of information to suggest that once we start vaccination and we get more than 25 percent of the population vaccinated, we will allow one of the variants that's in the background to emerge because it's resistant to the vaccine," board-certified internist and cardiologist, Dr. Peter McCullough, said in a podcast last month.
"Just like an antibiotic, once we get to a certain percentage of coverage with an antibiotic, we'll allow resistant bacteria to move forward."
Dr. Robert Malone, the inventor of mRNA and DNA vaccines, recently tweeted: "I am reminded of the first rule of holes. When you are in one, stop digging." He described booster shot strategies as "based on hope rather than data." (Related: Scientists increasingly question the necessity of booster shots; no data show they will help at all.)
"We could be digging ourselves into a hole for a very long time if we think we can only keep COVID away by boosting every year," said Eleanor Riley, an immunologist from the University of Edinburgh.
Humans generally get a broader immune response after being infected with the virus than vaccination. "That means if you had a real humdinger of an infection, you may have better immunity to any new variants that pop up as you have immunity to more than just spike [protein]," said Riley.
It wasn't clear whether the decision to leave by Gruber and Krause had something to do with the FDA's quick approval of Pfizer's COVID-19 vaccine. The circumstances suggest there's likely a connection.
The FDA had faced growing pressure to speed up the review of COVID-19 vaccines as cases surged among Americans from the fast-spreading delta variant of the virus. By granting full approval to Pfizer's COVID-19 vaccine, the FDA opened the door for more mandatory vaccinations in universities, companies and local governments.
National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci even told CNN that the time has come for a nationwide vaccine mandate.
"I know I respect people's freedom, but when you're talking about a public health crisis that we've been going through for well over a year and a half, the time has come," Fauci said. "Enough is enough."
That same line might have entered the minds of Gruber and Krause as they finally refused to get further tagged along for the ride: "Enough is enough."
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